NCT07724093

Brief Summary

The purpose of this study is to assess the immediate effects of a commercially available non-FDA regulated powered hip flexion assist device (Hypershell X, Shenzhen, China) on walking ability in persons with MS. The main question it aims to answer is: Does a powered hip flexion device provide immediate improvements in walking ability over short distances for people with MS?

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
21mo left

Started Jul 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress3%
Jul 2026May 2028

First Submitted

Initial submission to the registry

July 14, 2026

Completed
1 day until next milestone

Study Start

First participant enrolled

July 15, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 23, 2026

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2028

Last Updated

July 23, 2026

Status Verified

July 1, 2026

Enrollment Period

10 months

First QC Date

July 14, 2026

Last Update Submit

July 20, 2026

Conditions

Multiple Sclerosis (MS) Relapsing Remitting

Keywords

Multiple sclerosisgaitexoskeletonhip flexion orthosis

Outcome Measures

Primary Outcomes (2)

  • Gait speed

    Gait speed measured during a 10 meter walk

    Day 1 (immediate effect of device use)

  • Foot clearance

    Distance that the foot clears the ground during the swing phase of gait

    Day 1 (immediate effect of device use)

Secondary Outcomes (3)

  • Step length

    Day 1 (immediate effect of device use)

  • Circumduction

    Day 1 (immediate effect of device use)

  • Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST 2.0)

    Day 1 (immediate effect of device use)

Study Arms (1)

Hip flexion assist

EXPERIMENTAL

Participants will perform a series of 10 meters walks while wearing the hip flexion assist device under the following conditions. 1. No assistance (passive mode) 2. 25% power assistance 3. 50% power assistance 4. 75% power assistance During the trial subjects will wear motion sensors that provide the following gait parameters: speed, step and stride length, foot clearance, foot angle at heel strike, circumduction, single and double support time.

Device: Powered Hip Flexion Orthosis (Hypershell X)

Interventions

Powered Hip Flexion Orthosis (Hypershell X)DEVICE

Participants will perform a series of 10 meters walks while wearing the hip flexion assist device under the following conditions. 1) No assistance (passive mode) 2) 25% power assistance 3) 50% power assistance 4) 75% power assistance During the trial subjects will wear motion sensors that provide the following gait parameters: speed, step and stride length, foot clearance, foot angle at heel strike, circumduction, single and double support time.

Hip flexion assist

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18-80
  • Diagnosis of relapsing remitting, primary progressive or secondary progressive MS
  • Unilateral or bilateral hip flexion weakness (Manual muscle testing score of 3 or less)
  • Ability to walk at least 30 meters without requiring rest and without physical support or assistance from another person.
  • Waist circumference 26-48", Height 5 '- 6'2", Weight 100-230lbs

You may not qualify if:

  • Prior regular use of a hip flexion orthosis within the past 6 months.
  • Cognitive or communication deficits that would limit ability to participate safely.
  • Significant pain or deformity of the lower extremities that could impact walking ability.
  • Severe spasticity (Modified Ashworth Score of 3 or 4) of the hips or lower extremities that could impact walking ability.
  • Any other neurological conditions that may affect gait.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Dayton

Dayton, Ohio, 45469, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-RemittingMultiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Central Study Contacts

Kurt Jackson, PhD

CONTACT

937-229-5605Kjackson1@udayton.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: This is an exploratory case series
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor - Department of Physical Therapy

Study Record Dates

First Submitted

July 14, 2026

First Posted

July 23, 2026

Study Start

July 15, 2026

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

May 1, 2028

Last Updated

July 23, 2026

Record last verified: 2026-07

Locations

US(1)